Global Medical Devices Regulatory & Quality Associate

ProductLife Group; Paris; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities for medical devices across international markets, helping ensure compliance with MDR, IVDR, ISO 13485, and related standards while contributing to a wide range of client projects.

In this role you will prepare and maintain technical documentation, reviews of labeling, CAPA processes, and participate in audits.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field.
• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Knowledge of MDR, IVDR, ISO 13485, Technical Documentation, CAPA, and quality systems.
• Excellent organizational and communication skills.
• Fluent in French and English.

Responsabilités

• Support regulatory affairs activities for medical devices across international markets.
• Prepare, maintain, and review quality documentation including SOPs, working instructions, and templates.
• Contribute to the preparation and maintenance of Technical Documentation, STEDs, and Declarations of Conformity.
• Review Labelling and advertising documents.
• Support CAPA management, non-conformity investigations, and quality improvement activities.
• Participate in internal and external audits, including ISO 13485-related activities.
• Support regulatory registration and approval activities, including EU and FDA-related projects.
• Monitor regulatory developments and assess their impact on projects and processes.
• Contribute to KPI tracking and reporting through PLG systems and tools.
• Collaborate with cross-functional and international teams to deliver high-quality client services.

Connaissances

Regulatory Affairs

Quality Assurance

MDR/IVDR knowledge

CAPA

Quality Systems

Formation

Bachelors in Life Sciences

Pharmacy

Biomedical Engineering

Regulatory Affairs

Description du poste

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities for medical devices across international markets, helping ensure compliance with MDR, IVDR, ISO 13485, and related standards while contributing to a wide range of client projects.

In this role you will prepare and maintain technical documentation, reviews of labeling, CAPA processes, and participate in audits.